Clinical Trial of the Safety and Efficacy of the Addition of Ramucirumab to Nab-paclitaxel in Previously Treated Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

NCT02730247 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 15-169
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The subjects who take part in this clinical research study have advanced non-small cell lung cancer (NSCLC) that has been previously treated with other drugs. If they join this study, they would receive ramucirumab (Cyramza ®) in combination with nab-paclitaxel (Abraxane®). Ramucirumab given with nab-paclitaxel is considered an investigational drug combination to use in this type of cancer because giving these two drugs together has not been approved by any regulatory authority like the US Food and Drug Administration (FDA) for NSCLC cancer. Ramucirumab works by slowing or stopping the growth of cancer cells. Nab-Paclitaxel works by blocking the ability of cancer cells to break down the internal 'skeleton' that allows them to divide and multiply. With the skeleton still in place, the cells cannot divide and they eventually die.

Conditions

Non-small Cell Lung Cancer

Keywords

ramucirumab; docetaxel

Outcome Measures

Primary Outcomes (5)

• Progression-free Survival (PFS)

  The duration of time from start of treatment to time of progression or death. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

  Up to 26 months

• Worst Grade of Adverse Event Experienced

  Percentage of patients that experienced Grade 3-5 adverse events as their highest Grade event, irrespective of relatedness to treatment, per NCI CTCAE v2.0 (National Cancer Institute Common Terminology Criteria for Adverse Events).

  Up to 26 months

• Worst Grade of Adverse Event Experienced, at Least Possibly Related to Treatment

  Percentage of patients who experienced Grade 2-5 adverse events as their highest Grade event, that were at least possibly related to treatment, per NCI CTCAE v2.0 (National Cancer Institute Common Terminology Criteria for Adverse Events).

  Up to 26 months

• Worst Grade of Adverse Event Experienced, at Least Probably Related to Treatment

  Percentage of patients who experienced Grade 0-4 adverse events as their highest Grade event, that were at least probably related to treatment, per NCI CTCAE v2.0 (National Cancer Institute Common Terminology Criteria for Adverse Events).

  Up to 26 months

• Worst Grade of Adverse Event Experienced, Definitely Related to Treatment

  Percentage of patients that experienced Grade 0-2 adverse events as their highest Grade event, that were definitely related to treatment, per NCI CTCAE v2.0 (National Cancer Institute Common Terminology Criteria for Adverse Events.

  Up to 26 months

Secondary Outcomes (3)

• Best Overall Response

  Up to 26 months

• Overall Survival (OS)

  Up to 26 months

• Median EuroQol Five Dimension Questionnaire (EQ-5D-5L) Score

  Baseline through up to 26 months

Study Arms (1)

ramucirumab + nab-paclitaxel

EXPERIMENTAL

Ramucirumab will be administered through a vein in the arm as a 60 minute infusion at a dose of 8 mg/kg on days 1 and 15 of a 28-day cycle. The nab-paclitaxel will be administered through a vein in the arm as a 30 minute infusion at a dose of 100 mg/m2 on days 1, 8 and 15 of a 28 day cycle.

Drug: ramucirumab; Drug: nab-paclitaxel

Interventions

ramucirumab DRUG

it is administered through a vein in the arm as a 60 minute infusion at a dose of 8 mg/kg on days 1 and 15 of a 28-day cycle.

Also known as: Cyramza

ramucirumab + nab-paclitaxel

nab-paclitaxel DRUG

it is administered through a vein in the arm as a 30 minute infusion at a dose of 100 mg/m2 on days 1, 8 and 15 of a 28 day cycle.

Also known as: Abraxane

ramucirumab + nab-paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must have or meet the following:
• Histologically or cytologically confirmed Stage IV (AJCC 7) non-small cell lung cancer.
• Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.
• Received at least one prior platinum-based chemotherapy for locally advanced or metastatic disease. Prior bevacizumab as 1st line and/or maintenance therapy is allowed. Prior nivolumab is allowed.
• Age ≥18 years.
• ECOG performance status ≤2
• Life expectancy of greater than 12 weeks.
• Adequate liver function
• Adequate hematologic function
• Not have cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
• Adequate renal function
• Urinary protein of ≤1+ on dipstick or routine urinalysis (UA).
• Adequate coagulation function. Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy.
• Treated and clinically stable brain metastases are allowed.
• Adequate contraceptive use.

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Patients with previous intolerance to ramucirumab.
• Patients who are receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ramucirumab or nab-paclitaxel.
• Patients with untreated CNS metastases.
• Patients with significant bleeding disorders, vasculitis, or who experienced Grade 3/4 gastrointestinal (GI) bleeding within 3 months prior to enrollment.
• History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to enrollment.
• Any arterial thromboembolic events, within 6 months prior to enrollment.
• History of uncontrolled hereditary or acquired thrombotic disorder.
• Uncontrolled or poorly-controlled hypertension.
• A serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment.
• Major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment.
• Chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted.
• Elective or planned major surgery scheduled during the course of the clinical trial.
• Hemoptysis (defined as bright red blood or ≥ 1/2 teaspoon) within 2 months prior to enrollment, or with central or cavitating lesions.

Sponsors & Collaborators

• Liza Villaruz, MD: lead

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Ramucirumab; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins

Results Point of Contact

• Title: Barbara Stadterman, MPH, MCCR; CRS Regulatory Supervisor
• Organization: UPMC Hillman Cancer Center

stadtermanbm@upmc.edu

412-647-5554

Study Officials

• Liza Villaruz, MD

  University of Pittsburgh Cancer Institute, Department of Hematology Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Division of Hematology Oncology

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: April 6, 2016
• Study Start: July 5, 2017
• Primary Completion: September 8, 2019
• Study Completion: September 8, 2019
• Last Updated: November 19, 2020
• Results First Posted: November 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)